Sensorion's New Drug: SENS-401

Discussion in 'Research News' started by nononeac, Oct 3, 2016.

    1. Charles_T
      Insomnious

      Charles_T Member

      Location:
      California
      Tinnitus Since:
      06/2017
      Cause of Tinnitus:
      Ototoxicity or Benzo Withdrawal
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    2. Kraazy

      Kraazy Member

      Tinnitus Since:
      2014
      Cause of Tinnitus:
      Trauma
      Hello,

      I am trying to inform you about the latest results from Sensorion for their treatment called: "SENS-401" I'm French, and I found an English link, so I'm coming to post it to give you some good news. Sorry if my english is sad, I translate it with internet.

      https://www.businesswire.com/news/h...Sensorion-Presents-New-SENS-401-Data-ARO-2018

      I wish you lots of good things, and do not hesitate to come and ask me news about French research.

      Aurelian.
       
    3. Coleoptere
      Alone

      Coleoptere Member

      Location:
      The Hague
      Tinnitus Since:
      2002
      Cause of Tinnitus:
      Bell's Palsy, hearing loss
      Thank you Aurelian,

      Not sure this was clear before:

      ".... Clinical trial planning is ongoing and Sensorion intends to initiate a phase 2 study with SENS-401 in this indication during the first half of 2018."

      So we have a third trial planned in 2018 for hearing loss. I'm very curious how SENS-401 actually repairs the inner ear.
       
    4. Kraazy

      Kraazy Member

      Tinnitus Since:
      2014
      Cause of Tinnitus:
      Trauma
      Sorry, I had not seen that one the conversation dedicated for Sensorion.
      I am curious also. Apparently, it would be compressed(restrained) to set during 28 days, but it seems to me "too easy" to get back the hearing after a month. i have T since 4 years and H since 1 year but I am sure that 2018 will be beneficial for us

      #Hope
       
    5. Benoves

      Benoves Member Benefactor

      Tinnitus Since:
      26-9-2017
      Cause of Tinnitus:
      Unknow possibly noise trauma
      Isn't it only for acute hearing loss? Or are they able to restore hearing after a year?
       
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    6. Coleoptere
      Alone

      Coleoptere Member

      Location:
      The Hague
      Tinnitus Since:
      2002
      Cause of Tinnitus:
      Bell's Palsy, hearing loss
      "Early clinical data for SENS-401 have previously provided compelling scientific rationale for further clinical evaluation. Pre-clinically, oral doses of SENS-401 versus placebo were tested in models of severe noise-induced hearing loss and cisplatin induced ototoxicity. In both models, SENS-401 demonstrated significant improvement of hearing and enhancement of outer hair cell survival vs placebo"

      So I understand it works for hearing loss as well. It does not sound spectacular but who knows. Unfortunately no reports with results achieved in the lab.
       
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    7. Autumnly
      Wishful

      Autumnly Member Podcast Patron Benefactor Hall of Fame Advocate

      Location:
      Germany
      Tinnitus Since:
      July/August 2013
      Cause of Tinnitus:
      Noise induced
      Isn't it only for acute hearing loss (sudden sensorineural hearing loss (SSNHL))?

      SENS-401, the Company’s drug candidate being developed for the treatment of acute sensorineural hearing loss

      A first-in-class drug to treat Sudden SensoriNeural Hearing Loss (SSNHL).
      • To protect against inner ear lesions that lead to nerve degeneration and hair cells loss
      • Received Orphan Drug Designation in Europe for treating SSNHL
      SSNHL is also known as sudden deafness and belongs to the group of rare conditions that affect the inner ear (Rapid (instant or in <72 hours) hearing loss typically unilateral)

       
    8. Coleoptere
      Alone

      Coleoptere Member

      Location:
      The Hague
      Tinnitus Since:
      2002
      Cause of Tinnitus:
      Bell's Palsy, hearing loss
      I think that after re-reading the article it is acute HL. Sorry for the confusion.
       
    9. Kritish Gooriah
      Buzzed

      Kritish Gooriah Member

      Location:
      Lille (France)
      Tinnitus Since:
      07/2017
      Cause of Tinnitus:
      ear surgery acoustic trauma tmj ETD
      Sensorion (FR0012596468 – ALSEN) (Paris:ALSEN), a biotech company specializing in the treatment of inner ear diseases, today announces new data presented in multiple poster presentations at the Association for Research in Otolaryngology’s (ARO) 41st Annual MidWinter Meeting in San Diego, California, which took place February 9th to 14th, 2018.

      SENS-401 translational research:

      • Twice versus once daily oral dosing of SENS-401 for 28 days reveals exposure duration driven treatment effect against severe acoustic trauma induced hearing loss in rats.
      This study compared the efficacy of twice daily low dose versus once daily high dose oral administration of SENS-401, and results suggested that the daily duration of drug exposure is more important than maximal dose drug exposure for the otoprotective efficacy of SENS-401. Results also showed that a 28-day treatment provides better hearing outcome than a 14-day treatment. There is currently no approved pharmaceutical treatment for hearing loss. SENS-401 is Sensorion’s clinical-stage small molecule drug candidate with orphan drug designation for treatment of Sudden Sensorineural Hearing Loss (SSNHL) and cisplatin-induced ototoxicity (CIO), and has previously demonstrated an ability to reduce hearing loss and enhance survival of outer hair cells of rats exposed to acoustic trauma or cisplatin infusion.

      • Translational development of the clinical stage oral otoprotectant SENS-401 for sensorineural hearing loss.
      Early clinical data for SENS-401 have previously provided compelling scientific rationale for further clinical evaluation. Pre-clinically, oral doses of SENS-401 versus placebo were tested in models of severe noise-induced hearing loss and cisplatin induced ototoxicity. In both models, SENS-401 demonstrated significant improvement of hearing and enhancement of outer hair cell survival vs placebo. Additionally, pharmacokinetic profile and dose dependency were evaluated. A phase 1 clinical trial demonstrated that SENS-401 was well tolerated by patients and determined that the clinical pharmacokinetic profile is consistent with the drug exposures needed for preclinical efficacy. Clinical trial planning is ongoing and Sensorion intends to initiate a phase 2 study with SENS-401 in this indication during the first half of 2018.

      Tinnitus preclinical research:

      • Tinnitus or Hearing Loss? Relationship between GPIAS deficits and ABR thresholds after repeated salicylate administration in rats.
      The gap-prepulse inhibition of acoustic startle (GPIAS) paradigm using salicylate induction is widely used in preclinical settings for the study of tinnitus. The GPIAS behavioral paradigm measures the ability of a silent gap in background noise to inhibit the startle response to a loud noise. Salicylate is often used because it rapidly induces deficits in startle inhibition by gap-detection which are interpreted as tinnitus-related. However, recent work emphasizes that hearing loss can be a confounding variable using the GPIAS paradigm, rendering a straightforward interpretation of gap-detection deficits as a clear measure of tinnitus difficult. This study demonstrated that there is a strong relationship between salicylate-induced hearing loss and gap-detection deficits using the GPIAS paradigm. Results from this study emphasize the need for concurrent control measurements of hearing ability when using the GPIAS paradigm to assess tinnitus, particularly in animal models with bilateral hearing impairment.

      https://www.businesswire.com/news/h...Sensorion-Presents-New-SENS-401-Data-ARO-2018
       
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    10. Aaron123

      Aaron123 Member

      Tinnitus Since:
      00/0000
      Cause of Tinnitus:
      Irrelevant
      Sensorion will be presenting some preclinical results at the American Neurotology Spring meetings: http://www.sensorion-pharma.com/images/press_release/20180409-PR-EN-ANS-COSM_Curtain_Raiser-VF.pdf Title of the presentation is "The Clinical Stage Otoprotectant SENS-401 Effectively Reduces Hearing Loss in Rats When Administered up to 96 hours after Severe Acoustic Trauma"

      They are also presenting a paper on a blood biomarker for hearing loss.

      They have also posted their 2017 corporate results: http://www.sensorion-pharma.com/ima..._Annual-2017-Financials-results-VF11april.pdf
       
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    11. jer

      jer Member

      Tinnitus Since:
      06/2015
      Cause of Tinnitus:
      Acoustic trauma
      Even if it is only for acute hearing loss. Just because we have tinnitus, doesn't mean that we cannot get more acute hearing loss stacked upon our already existing hearing loss.

      Just imagine the scenario where you have to take a medication that you know is ototoxic but you have no choice. Or you experience major hearing loss through other reasons.

      Wouldn't it be nice to have a medicine that could protect your ear from any further hearing loss and therefore more tinnitus? I for one would be super excited to have that option.
       
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    12. Aaron123

      Aaron123 Member

      Tinnitus Since:
      00/0000
      Cause of Tinnitus:
      Irrelevant
      In this (https://globenewswire.com/news-rele...ed-Up-to-Four-Days-after-Acoustic-Trauma.html) ridiculously hyped press release we learn a bit of interesting information. (In addition to the hype, its very odd they talk about SSNHL after acoustic trauma. Part of why SSNHL is challenging in that there is no obvious cause.)

      Anyway, here is the interesting bit with emphasis added "In the study, beginning from 24 to 96 hours after severe acoustic trauma, rats orally received either 13.2 mg/kg SENS-401 or placebo control twice daily for 28 days. Hearing outcomes and otoprotection were evaluated via auditory brainstem response (ABR) and distortion product otoacoustic emission (DPOAE) testing as well as cochleograms. SENS-401 treatment significantly improved recovery of hearing loss in rats when initiated up to 96 hours after severe acoustic trauma (p=0.006) as well as enhancing the survival of sensory outer hair cells (p=0.027). "

      The improvement in hearing loss is of course a good thing, but preserving outer hair cells is very important for improving thresholds. With p=0.027, it's not hugely statistically significant, but any evidence of this is a good thing.
       
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    13. jeff W

      jeff W Member

      Location:
      nakatomi plaza
      Tinnitus Since:
      04/2012
      Agreed
      Its a classic pump and dump.
      Shareholders probably paid for this press release and have their fingers on the trigger, but the market does not seem to be fooled.
      31224226_1922340737777201_5917286416336814080_o.jpg
       
    14. Tigo

      Tigo Member

      Tinnitus Since:
      2 years
      Cause of Tinnitus:
      genetic hearing loss
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    15. Arseny
      Wishful

      Arseny Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      Possibly from problems with blood flow
      http://www.sensorion-pharma.com/images/press-release/20181221-PR-SENS401-OtoNeuroJournal.pdf

      The Sensorion pre-clinical team tested the efficacy of SENS-401 against severe acoustic trauma-induced hearing loss in a male rat model using auditory brainstem response (ABR), distortion product otoacoustic emissions (DPOAE) and histology. Results showed that twice daily, lower doses of SENS-401 for 28 days was the optimal dosing regimen for hearing protection using all outcome measures. Further experiments demonstrated that this treatment regimen was able to deliver clinically relevant and statistically significant otoprotection and hearing recovery when the administration was delayed by as much as 96 hours after acoustic trauma (the latest treatment initiation time-point tested). A responder analysis showed that oral SENS-401 treatment not only strongly increased the percentage of subjects with clinically significant hearing recovery compared to placebo, but also enhanced the degree of individual hearing recovery observed. These data on otoprotection and hearing recovery supports SENS-401 as a promising clinical candidate for acute onset sensorineural hearing loss, including when treatment is not initiated immediately. “These results provide support for the translational development of SENS-401 in sudden sensorineural hearing loss (SSNHL) and publication in the respected Otology & Neurology journal also provides additional important peer-validation,” says Nawal Ouzren, Sensorion’s Chief Executive Officer. “SENS-401 offers the potential to make a real difference to patients’ lives as a potential first-in-class treatment, and we look forward to starting the Phase 2 of SENS-401 in SSNHL for which we received the authorization in Europe and Canada.”
       
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    16. reggie green
      Balanced

      reggie green Member

      Tinnitus Since:
      03/08/2001
      Sensorion (ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biopharmaceutical company which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, tinnitus and vertigo, today announced that the independent Data Safety Monitoring Board (or DSMB) has undertaken a review of the safety data for the 76 first patients having completed the phase 2 clinical trial for SENS-111 in the treatment of acute unilateral vestibulopathy(AUV).

      https://www.marketwatch.com/press-r...cute-unilateral-vestibulopathy-auv-2019-05-15
       
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    17. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
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